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【資料３】令和５年度欧米の市販後安全対策を中心とした薬事制度に関する調査［3.1MB］ (14 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_38915.html |
| 出典情報 | 医薬品等行政評価・監視委員会（第15回 3／22）《厚生労働省》 |
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2021年-2024年 Non-renewal件数
2021年度 Non-renewal
Renewal件数
EMA 2021 Annual Activity Reportより(2022年6月発行)https://www.ema.europa.eu/en/documents/report/annual-activity-report-2021_en.pdf
2022年度 Non-renewal
Renewal件数
0件/123件
0件/132件
EMA 2022 Annual Activity Reportより(2023年6月発行) https://www.ema.europa.eu/en/documents/report/annual-activity-report-2022_en.pdf
2023年度 Non-renewal
0件/申請件数未発表 (2024年6月頃発表）
2024年度 Non-renewal 件数未発表だが、既に2件のNon-renewal CHMP勧告有
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-25-29-january-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-22-25-february-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-22-25-march-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-april-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-17-20-may-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-june-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-july-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-written-procedure-16-19-august2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-13-16-september-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-11-14-october-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-8-11-november-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-13-16-december-2021_en.pdf
https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-multiplemyeloma-medicine-blenrep
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-24-27-january-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-february-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-march-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-april-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-16-19-may-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-20-23-june-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-18-21-july-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-written-procedure-16-19-august-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-12-15-september-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-10-13-october-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-7-10-november-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-12-15-december-2022_en.pdf
https://ec.europa.eu/health/documents/community-register/2024/20240223161678/anx_161678_en.pdf
https://ec.europa.eu/health/documents/community-register/2024/20240223161678/dec_161678_en.pdf
https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna
14
2021年度 Non-renewal
Renewal件数
EMA 2021 Annual Activity Reportより(2022年6月発行)https://www.ema.europa.eu/en/documents/report/annual-activity-report-2021_en.pdf
2022年度 Non-renewal
Renewal件数
0件/123件
0件/132件
EMA 2022 Annual Activity Reportより(2023年6月発行) https://www.ema.europa.eu/en/documents/report/annual-activity-report-2022_en.pdf
2023年度 Non-renewal
0件/申請件数未発表 (2024年6月頃発表）
2024年度 Non-renewal 件数未発表だが、既に2件のNon-renewal CHMP勧告有
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-25-29-january-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-22-25-february-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-22-25-march-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-april-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-17-20-may-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-june-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-july-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-written-procedure-16-19-august2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-13-16-september-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-11-14-october-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-8-11-november-2021_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-13-16-december-2021_en.pdf
https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-multiplemyeloma-medicine-blenrep
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-24-27-january-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-february-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-march-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-april-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-16-19-may-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-20-23-june-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-18-21-july-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-written-procedure-16-19-august-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-12-15-september-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-10-13-october-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-7-10-november-2022_en.pdf
https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-12-15-december-2022_en.pdf
https://ec.europa.eu/health/documents/community-register/2024/20240223161678/anx_161678_en.pdf
https://ec.europa.eu/health/documents/community-register/2024/20240223161678/dec_161678_en.pdf
https://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-duchenne-muscular-dystrophy-medicine-translarna
14